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I will design and analyze doe studies for pharmaceutical process characterization
Pharmaceutical Statistician, DoE, QbD, GMP, CMC, Process Validation
I'm a pharma statistician with 20+ years of experience in API manufacturing — first as a chemical process developer, then as a CMC/MSAT statistician. I understand your process, not just your data.
I s...
About this Gig
Are you developing or optimizing a pharmaceutical manufacturing process and need rigorous, audit-ready statistical support for your Design of Experiments?
I bring 20+ years of hands-on experience in API manufacturing first as a chemical process developer, then as a CMC/MSAT statistician. I don't just run the numbers: I understand the chemistry, the GMP constraints, and what the results actually mean for your process.
What I can help you with:
- Screening designs (Plackett-Burman, fractional factorial) to identify critical process parameters (CPPs)
- Response Surface Methodology (RSM) for process optimization and design space definition
- Mixture designs for formulation studies
- Full factorial and custom designs for robustness studies
- Statistical analysis, interpretation, and report writing (Minitab, MODDE, R, Python)
- QbD-aligned documentation suitable for CMC regulatory submissions
What you'll receive:
- A clear, well-structured statistical report
- Interpretation grounded in process knowledge, not just p-values
- Deliverables formatted for internal use or regulatory review
Typical clients: pharma/biotech companies, CROs, MSAT and R&D teams without dedicated statistical support.
Not sure if you
FAQ
Q: I don't have data yet — can you still help me?
Absolutely. The most valuable part of DoE work happens before you run the experiments. I can help you define the right design for your objectives: select factors and ranges, the appropriate design and prepare the experimental plan. You then run the experiments and come back to me for the analysis.
Q: Which software do you use, and will I receive editable files?
I work primarily in R. You will always receive the analysis outputs and the final report. If you need the original project files (only R scripts), just mention it when ordering — I'll include them at no extra cost.
Q: My study involves confidential process data. How do you handle that?
I treat all client data as strictly confidential. If your organization requires an NDA before sharing process information, I'm happy to sign one prior to starting work. Just send me a message before ordering and we'll arrange it.
Q: Can the deliverables be used directly in a regulatory submission (CMC dossier)?
The Standard and Premium packages include documentation written with regulatory review in mind — methodology, assumptions, results, and conclusions are structured in line with ICH Q8/Q10 expectations. That said, final formatting and integration into your dossier remain your team's responsibility.
Q: My project doesn't fit neatly into Basic, Standard, or Premium. Can we do something custom?
Yes, and I'd encourage you to reach out before ordering if you're unsure. Send me a brief description of your study — objectives, number of factors, whether you have data already — and I'll propose the right scope and price. I'd rather scope the work correctly upfront than have surprises mid-project
Q: What if I need revisions beyond the included number?
Additional revisions are available at €40 each. In practice, revisions are rare when the scope is well-defined upfront — which is why I recommend a brief message before ordering for anything beyond straightforward projects.
